Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Monograph for Combination Drug Products; Correction
other · Food and Drug Administration · Rule · Published 2003-04-14 · Effective 2004-12-23 · 68 FR 17881
Document
Document number
03-9067
Federal Register citation
68 FR 17881
CFR reference
21 CFR 341
Type
Rule
Action
Final rule; correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-04-14
Effective date
2004-12-23
HHS docket
Docket No. 76N-052G
Abstract
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of December 23, 2002 (67 FR 78158). The document issued a final monograph that established conditions under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products.